1. Field of the Invention
The present invention is directed to an arrangement for reading and evaluating data from a biosensor array (biochip) for medical diagnostic purposes.
2. Description of the Prior Art
It is well-known that the presence of certain biomolecules, such as a particular protein, antibody or DNA fragment, in the human body is correlated with certain diseases, and therefor it is also known to make a medical diagnosis based on identification of the presence of these biomolecules. If the presence of a certain molecular species at a certain concentration level in the human body has been shown to be correlated with the presence or absence of a particular pathology (disease), the relevant biomolecule is referred to as a diagnostic marker for the pathology. For most diseases, the pathological reaction chain is very complex, and involves a large number of different biomolecules which, in turn, also may play a role in the pathophysiology of another disease. Therefore, a single marker is not always sufficient in order to unequivocally diagnose a particular disease. Often, it is only through an evaluation protocol involving several combined markers that a diagnosis can be made. For example, if a concentration is high for a first marker, low for a second marker, and a third marker is absent, then a particular disease can be diagnosed. The measurement of single markers or multiple markers is referred to as an in vitro diagnostic test. The development of markers for such diagnostic tests is very cost intensive and time intensive, and the development of expert rules for such tests is even more cost intensive and time intensive. The establishment of a marker rule or a multi-marker rule requires a procedure known as a clinical test or clinical study (sometimes merely called a “clinical”). The clinical study includes measuring candidate markers in a large number of patients, usually hundreds to thousands of patients. From such data, a diagnosis standard is established, which will always have a certain error associated therewith. In order to determine whether the error is within an acceptable range, as well as to determine whether refinements or modifications in the standard reduces the error, it is necessary to retrospectively correct results which are “predicted” by the standard with actual follow-up examinations of the patients. The results from such a clinical study are the basis for approval of such a diagnostic test by a national authority, such as the FDA in the United States.